適應症
放射免疫法測定B型肝炎E抗原(HBEAG)或B型肝炎E抗體(ANTI-HBE) 
劑型
 
包裝
 
許可證字號
衛署醫器製字第R01235號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2024-11-06  
發證日期
2005-01-10  
許可證種類
09 
中文品名
普生益肝碘125BN 
英文品名
EIDINE 125 BN 
藥品類別
B 血液學及病理學裝置 
申請商名稱
普生股份有限公司  
申請商地址
新竹縣寶山鄉新竹科學園區創新一路6號 
通關簽審文件編號
DHY005R0123500 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
普生股份有限公司 新竹縣寶山鄉新竹科學園區創新一路6號 TW
成份表
處方標示 成分名稱 含量 單位
1 每套組含:1.Anti-HBe beads: One dispenser contains 100 beads coated with human antibody to HBe Ag.2.125I‧Anti-HBe Solution: Two bottles, 10ml each or ten bottles, 2ml each with 125I labeled anti-HBe (human) dissolved in protein stabilizer. The maximum radioactivity was 3.5μCi/ml on iodinization day. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin. 3.HBeAg Positive Control: One bottle (2ml) containing HBeAg and HBsAg positive serum dissolved in buffer solution with protein stabilizer. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.4.HB Negative Control: One bottle (3ml) with normal human serum is free of HBeAg, anti-HBe and HBsAg, but contains protein stabilizers. Preservatives: Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.5.Anti-HBe positive control: one bottle (2ml) containing Anti-HBe and HBsAg positive serum sdissolved in buffer solution with protein stabillizer. Preservatives: 0.01% Thimerosal and 0.001% Gentamycin.6.Neutralizing solution for anti-HBe: One bottle (10ml) of diluted recalcified human plasma, reactive for HBeAg and HBsAg. reservatives: 0.01% Thimerosal and 0.001% Gentamycin.